Prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure (PräVAC)

Prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure (PräVAC) - PräVAC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005257

Enrollment

100

Registered

2013-08-29

Start date

2013-05-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wound complications penile cancer C60 T89.03

Interventions

Group 1: conventional compression bandages for 24 hours (standard treatment) on one side Group 2: epidermal negative-pressure wound dressings (Prevena) for 7 – 8 days of the other side

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients with penile cancer and indication for inguinal lymph node dissection (tumor stage > pT1 G2 or palpable inguinal enlarged lymph nodes) • Self-signed and –dated informed consent

Exclusion criteria

Exclusion criteria: • Previous inguinal surgery (e.g. after femoral bypass surgery) or other medical conditions already impairing lymphatic drainage (status post inguinal hernioplasty does not represent an exclusion criteria in case surgery hasn´t been performed within the last 3 months and no apparent impaired lymphatic drainage is present) • Patients unable to understand the patient information or unable to consent • Patients with known allergy to acrylic adhesive • Age below 18 years

Design outcomes

Primary

Measure	Time frame
cumulative drained exudate volume (ml) until removal of drainage (up to the 14th postoperative day)	—

Secondary

Measure	Time frame
A) maximal drained exudate volume per day (ml) B) duration of indwelling drainage (time until removal) C) incidence of wound-associated complications (lymph edema, lymphocele, lymphorrhea, wound dehiscence, wound infection, thrombosis) [Time Frame: inpatient discharge + 3 months postoperatively] D) duration of hospitalization E) comparison of lymph node dissection-associated rate of reintervention (recurrent placement of drainage, puncture, re-operation, irradiation therapy, other therapeutic interventions) [Time Frame: inpatient discharge + 3 months postoperatively] F) quality-of-life, patient´s satisfaction and comfort with wound treatment [Time Frame: preoperatively + inpatient discharge + 3 months postoperatively] -->QLQ-C30 (Version 3.0)	—

Measure

Time frame

A) maximal drained exudate volume per day (ml) B) duration of indwelling drainage (time until removal) C) incidence of wound-associated complications (lymph edema, lymphocele, lymphorrhea, wound dehiscence, wound infection, thrombosis) [Time Frame: inpatient discharge + 3 months postoperatively] D) duration of hospitalization E) comparison of lymph node dissection-associated rate of reintervention (recurrent placement of drainage, puncture, re-operation, irradiation therapy, other therapeutic interventions) [Time Frame: inpatient discharge + 3 months postoperatively] F) quality-of-life, patient´s satisfaction and comfort with wound treatment [Time Frame: preoperatively + inpatient discharge + 3 months postoperatively] -->QLQ-C30 (Version 3.0)

—

Countries

Germany

Contacts

Public ContactTobias Maurer

Urologische Klinik und Poliklinik am Klinikum rechts der Isar der Technischen Universität München

t.maurer@lrz.tum.de089/41 40-25 22

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026